1. Accrual Strategies The enrollment of study subjects Presented by Lena Marra,MA HAD Director of Research Department of Radiology Department of Radiology

2.  Successful recruitment of participants for any clinical trial is a challenge.  The majority of clinical trials are delayed due to low enrollment that can result in lost revenue.  The enrollment of subjects for your clinical trial is one of the most difficult and rate- limiting step for all studies.

3. Steps to examine before committing to a trial  Develop an understanding of the population being recruited  Master a clear insight of the inclusion/exclusion criteria  Seek collaboration from other colleagues and commit to building a close working relationship  Make sure that the PI and staff can commit the time needed to devote to the project  Adhere to the mandates of NIH-sponsored research in the recruitment of under-represented populations  Be aware of the evolving HIPAA regulations of directly contacting potential participants

4. Recruiting Basics  Direct advertising represents the majority of recruitment tools used by investigators to identify potential research subjects  Subjects need to be given sufficient, and accurate information to make an informed decision about their participation in a study  All subject recruitment materials must be reviewed and approved by the IRB before they are utilized

5. Recruitment possibilities  PI and Co-PI direct enrollment  Self-referral  Radio/TV  Printed material  Direct mail  Internet Web sites  Community Outreach  Recruitment Advertising Companies

6. What makes a good advertisement?  Study descriptions should be written in plain language and easily understood by the general public  Clearly state the condition or patient group under study and the purpose of the trial  The name of the investigator and the research facility should be visible  List contact numbers and e-mail if possible. Be certain the person answering the phone is knowledgeable about the study  Be explicit about what is expected of participants  Compensation should be stated without promise of benefit or inducement.  Flyers and brochures should be made available in different languages

7. To ensure subject retention  Schedule study visits at a convenient time for subjects  Maintain close communication with subjects and their families  Return phone calls promptly  Explain compensation

8. Summary  No single recruitment strategy may achieve enrollment goals.  The goal of any study should be to treat all volunteers in an ethical manner by respecting their decisions, protecting them from harm, and making every effort to secure their well-being.